Kornimate/medical-research-clean huggingface dataset:
measuring nerve activity in small human intestinal biopsies in ibs (irritable bowel syndrome)

Conditions: IBS; Healthy

Summary: rectal biopsies from ibs patients or healthy subjects will be taken. biopsies will be used for: 1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and calcium imaging; 1.2 immunohistochemistry; 1.3 mrna (messenger ribonucleic acids) isolation and real time pcr (polymerase chain reaction); 2. culturing biopsies on the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ens (enteric nervous system) in ibs by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. this development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation. in particular, the investigators aim: 1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and ibs patients; 2. to characterize this nerve activity in healthy subjects and ibs patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtpcr to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia; 3. to investigate whether the biopsies of ibs patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons. 4. to evaluate the influence of different food constituents (cow"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation/degranulation in biopsies of ibs patients compared to healthy subjects. 5. to evaluate the amount of inflammatory mediators/metabolites in urine samples of ibs patients and healthy volunteers by the use of metabolic profiling


Eligibility criteria:
inclusion criteria: * ibs patients (based on rome iii criteria) * healthy subjects exclusion criteria: - all subjects with not ibs related complaints

Keywords: ibs patients healthy subjects
haic plus lenvatinib and toripalimab for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (hcc)

hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (pd-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has evaluated haic plus lenvatinib and toripalimab. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic artery infusion chemotherapy oxaliplatin, 5-fluorouracil and leucovorin lenvatinib toripalimab
interdental plaque reduction and periodontitis

Conditions: Periodontitis

Summary: to determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores.

patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of probing pocket depth (ppd), presence of recession of the gingival margin (rec) and full mouth plaque score (fmps) will be recorded on six sites/tooth by a single calibrated examiner using a university of north carolina (unc) 15-mm periodontal probe by a calibrated examiner blind to group allocation. gingival index (gi) and angulated bleeding score (angbs) will be recorded at four sites/tooth. for gi the following scale will be used: 0 normal appearance of gingiva, no bleeding, no inflammation; 1. slight change and moderate edema with slight change in texture, no bleeding, mild inflammation; 2. redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation; 3. marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation. for angbs the following scale will be used: 0: no bleeding; 1. bleeding upon probe stimulation; 2. spontaneous bleeding consequently, interdental plaque score (ips), interdental gingival index (igi), and interdental angulated bleeding score (iangbi) will be calculated. patients will be followed through a five-week period. the timepoints will be the following: t -7 (oral hygiene instructions), t0 (professional supragingival scaling and polishing), t14, t28.

Eligibility criteria:
inclusion criteria: * males or females of age range between 18 and 70 years, * good health status, * presence of at least 20 natural teeth * residual periodontal pockets with ppd≥4mm, in need of specific oral hygiene regimen. exclusion criteria: * pregnancy or breast-feeding, * indication to antibiotic therapy prior to treatment, * chronic infections, * systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases), * not willing to give a consent
testing of the smartphone app to enhance hiv prevention cascade among malaysian msm

Conditions: HIV Prevention Program

Summary: the investigators will conduct a pilot rct to evaluate the feasibility and acceptability of the jomprep app and examine its preliminary efficacy in improving prep cascade compared with the control group.

mhealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations and link them to care. leveraging mhealth reduces individuals' discomfort and distrust of disclosing risk behaviors to providers, providers' low cultural competency for working with individuals of diverse sexual identities, and bypasses barriers to care for marginalized populations, - all features crucial for hiv prevention in msm in malaysia. results from the investigators' studies show malaysian msm often do not get hiv tested or initiate prep. mixed methods suggest msm want these services but prefer a streamlined system to access them that reduces interaction with clinicians where disclosure and perceived judgment occurs. mhealth may overcome these barriers by facilitating prevention services delivery and health decision-making in a confidential, less-stigmatizing, and convenient manner. overall smartphone growth in malaysia (63% in 2015 to 89% in 2017), and the investigators' parallel work with msm indicates that nearly all (\>97%) msm own a smartphone. findings from qualitative interviews with msm further indicate preferences for interfacing with 'apps' rather than health professionals as well as local stakeholders indicating strong interest in using such platform to deliver hiv prevention services align with developing culturally tailored mhealth strategies and to engage msm in virtual communication with providers - all embedded within one app. to the investigators' knowledge however, no mhealth intervention has been developed to improve access to hiv prevention services in malaysia. the investigators, therefore, propose to pilot test their new clinic-affiliated app (jomprep) to promote hiv testing and prep uptake in malaysian msm. they will conduct a pilot rct to evaluate the feasibility and acceptability of the jomprep app and examine its preliminary efficacy in improving prep cascade compared with the control group. the investigators will enroll 90 participants who will be randomized (1:1) to receive either the jomprep app or the control group and assessed at 3- and 6-months. randomization will be stratified by ats use (16% to 24%) and age. they will conduct exit interviews with participants and clinical staff to examine the barriers and facilitators to the app and obtain feedback to further optimize the app.

Eligibility criteria:
inclusion criteria: msm * hiv-negative msm * age more than or equal to 18 * cis-gender men * condomless sex in the last 30 days * own a smartphone exclusion criteria: * unable to provide informed consent * unable to read and understand english or bahasa malaysia

Keywords: mobile application prep mhealth
observational study of sub-populations from cologuard post-approval study (2014-01)

Conditions: Colorectal Cancer

Summary: the primary endpoint is to obtain longitudinal information on four sub-populations from the cologuard post-approval study.

subjects who consented to enroll in exact sciences protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. population 1 includes those whose cologuard t0 result was positive and colonoscopy result was negative. population 2 includes those whose cologuard t0 result was positive and subject declined to complete a colonoscopy per protocol. population 3 includes those whose cologuard result at t3 was positive and colonoscopy result at t3 was negative. population 4 includes those whose cologuard result at t3 was positive and subject declined to complete a colonoscopy per protocol. subjects that enrolled in the exact sciences protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the follow-up questionnaire during a phone interview.

Eligibility criteria:
inclusion criteria: * subject falls into one of the 4 sub-populations * willing to provide informed consent exclusion criteria: * death * investigator/sponsor decision * subject withdrew consent

Keywords: cologuard
safety and efficiency of γδ t cell against hematological malignancies after allo-hsct

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Lymphoma

Summary: this study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ t cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.

this is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ t cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ t cell will be separated from peripheral blood of the same donors. after expansion in vitro, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria:
inclusion criteria: 1. patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation； 2. age criteria: 18-65 years; 3. weight criteria: \> 40kg; 4. organ function criteria: cardiac function: left ventricular ejection fraction (lvef) ≥40%, pulmonary function: indoor oxygen saturation≥95%, alanine aminotransferase and aspartate aminotransferase ≤ 2.5×uln (upper limit of normal value), total bilirubin ≤ 1.5×uln, serum creatinine ≤ 1.5×uln; 5. life expectancy of at least 4 months; 6. ecog (eastern cooperative oncology group) score ≤ 2; 7. patients able to understand and sign written informed consent. exclusion criteria: 1. gvhd (graft versus host disease) ≥ grade ⅱ； 2. thrombotic microangiopathy； 3. posttransplant lymphoproliferative disorders； 4. uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)； 5. patients with chronic diseases that require treatment with immune agents or hormones; 6. suffering from systemic autoimmune disease or immunodeficiency disease; 7. systemic use of steroids; 8. allergic constitution; 9. hemorrhagic disease or coagulation disorders; 10. patients participating in other clinical trials within 30 days prior to enrollment; 11. patients receiving radiotherapy within 4 weeks prior to enrollment; 12. pregnant or breastfeeding women; 13. according to the researcher's judgment, the patient has other unsuitable conditions.
effects of kinesio taping for upper limb function of stroke patients

Conditions: Stroke

Summary: patients with stroke in the brain, due to central nervous system damage, lack of correct action patterns, limited joint movement of upper limbs, affecting the patient's performance. the kinesio taping effect is to facilitate the muscle activity of upper limb. this program is intended to provide a treatment for patients with chronic stroke, and to observe their upper limb movements before and after using the kinesio taping.

motor impairment is the main cause of disability after stroke, leading to major health problems. research has shown that the most common consequence of stroke is the paresis of limbs.the ability to live independently after a stroke depends on the recovery of motor functions,particularly those of the upper limb.the core concept of the kinesio taping is to influence the brain through the sensory input, stimulate the nervous system, and improve the motor performance of the stroke patient.

Eligibility criteria:
inclusion criteria: * post-stroke hemiplegia, at least 6 months since onset * ability to communicate and understand instructions. exclusion criteria: * skin problems, wounds, or infection on the affected upper limb. * the experience of using the kinesio taping. * a history of allergy tothe kinesio taping.
study to determine whether ramelteon helps people with rem sleep behavior disorder

Conditions: REM Sleep Behavior Disorder

Summary: the purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of rem sleep behavior disorder.

this is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of rbd. outcome measures are determined by change in rbd polysomnographic score and assessment scores on the rbd symptom questionnaire and sleep diary.

Eligibility criteria:
inclusion criteria: * meets criteria for rbd as determined by screening psg's * steady bed partner for completion of rbd questionnaire exclusion criteria: * hepatic impairment * rbd associated with narcolepsy * use of fluvoxamine, rifampin, fluconazole or ketoconazole * current alcohol or drug abuse
impact of cold ischemia on pulmonary endothelial dysfunction in ex-vivo pulmonary reconditioning

Conditions: Lung Transplant

Summary: the study population will be patients with planned double-lung transplant, with preoperative ex-vivo reconditioning procedure. the ex-vivo procedure will be performed for lungs considered as limit to be directly implanted according to the national classification or in case of maastrich 3 decision. they required a rehabilitation procedure like ex-vivo to determine their quality. once the procedure initiated, the unused remaining liquid will be retrieved for the first gasometry usually performed. this will be the time t1 of sampling. the unused remaining liquid will be retrieved for the gasometry of end of procedure usually performed, before the graft cooling. this will be the time t2. the purge liquid of first lung at the declamping of the pulmonary artery will be retrieved at the time of unclamping (time t3 of sampling). the purge liquid of the second lung at the declamping of the pulmonary artery will be retrieved with the same procedure (time t4 of sampling). the samples will be analysed with elisa technique. the endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-nos.


Eligibility criteria:
selection criteria: * patient aged \> 18 years old * patient with healthcare insurance * non-opposition of the patient * patient with usual criteria for lung transplant and planned lung transplant after meeting of staff transplant non selection criteria: * participation refusal * patient under tutorship or guardianship * protected adult inclusion criteria: * selected patient with biomedecine agency agreement for graft allocation off tour exclusion criteria: * selected patient with biomedicine agency agreement for standard allocation graft
escalated application of mesenchymal stem cells in amyotrophic lateral sclerosis patients

Conditions: Motor Neuron Disease

Summary: background: amyotrophic lateral sclerosis (als) is a neurodegenerative disease that selectively affects motor neurons in the brain and spinal cord, leading to bulbar, respiratory, and limb weakness. there is no effective treatment, and the disease usually progresses to death within 2 to 4 years. the therapeutic plasticity of mesenchymal stem cells (mscs) may be an attractive therapy to this complex disease, turning mscs strong candidates for cellular therapy in als. design-a phase 1 open-safety clinical trial. 4 patients will be selected according to a restricted inclusion and exclusion criteria and after 2 escalated infusions of mscs, there will be a follow up period of one year methods - primary endpoint: safety of mesenchymal autologous stem cells infusions escalated in two intrathecal administrations in patients with als defined as severe adverse events (sae). secondary endpoints: clinical response, laboratorial and magnetic resonance imaging of patients submitted to cellular escalating doses applied in the study. quality of life, according to el escorial criteria, alsfr scale and functional scales. conclusion: this study is a primary step before a large randomized double-blind clinical trial for als. it is expected to confirm the safety of escalated mscs therapy in als patients, initial data of efficacy in addition to improved quality of life.


Eligibility criteria:
inclusion criteria: * women and males over 18-year-old. * diagnosis of als in agreement with the criteria of "el score" * less than 24 months of evolution of the disease (from the beginning of the symptoms). * good understanding of the protocol and aptitude to grant the informed consent * infertile women (post-menopause or hysterectomized) * brazilian citizen and permanent resident. exclusion criteria: * any significant medical condition (congestive heart failure, angina, respiratory failure, and others) * any auto-immune disease * any malignant diseases * systemic infection * mental illness * depressive state

Keywords: amyotrophic lateral sclerosis
stool microbiome, pathogens, and infectious agents among olympic and elite athletes

Conditions: Athletic Performance

Summary: this research is being done to investigate fecal microbiome and metabolome as well as serum analytes and single nucleotide polymorphisms in olympic athletes in comparison with other elite athletes.

olympic athletes, non-olympic elite athletes, and other active adults may have genetic and metabolic profiles that are unique. these profiles may contribute to the caliber of their athletic performance, and they may provide keys to understanding select genetic and metabolic conditions. therefore, the specific aims of this project are as follows: * specific aim 1: characterize the fecal microbial communities in athletes participating in the summer 2016 games and in athletes not participating in the olympic games * specific aim 2: characterize the fecal microbiome metabolome (untargeted) in athletes participating in the summer 2016 games and in athletes not participating in the olympic games * specific aim 3: characterize selected serum analytes and single nucleotide polymorphisms (snps) of elite athletes participating in the summer 2016 games and in athletes not participating in the olympic games, via serum and saliva analyses, respectively * specific aim 4: retain specimens from olympic athletes participating in the summer 2016 games and in athletes not participating in the olympic games for future research * specific aim 7: examine for the presence of zika virus rna in study participants who exhibit symptoms stool, urine, and blood specimens will be collected to study the stool metabolome, as well as serum analytes and single nucleotide polymorphisms, and the nature and extent of exposure to pathogens and infectious agents. these will be compared between olympic athletes and other non-olympic elite athletes.

Eligibility criteria:
inclusion criteria: * member of the summer 2016 u.s. olympic team and/or other elite athlete * english speaking * willing to provide informed consent and biospecimens * willing to complete questionnaires regarding normal bowel habits and general health exclusion criteria: * none

Keywords: stool microbiome stool metabolome single nucleotide polymorphisms
study to determine the safety, tolerability, and pharmacokinetic (pk) profile of egt0001474 in healthy volunteers

Conditions: Safety and Tolerability of EGT0001474 in Healthy Volunteers

Summary: this study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of egt0001474.

egt0001474 is an inhibitor of human sodium dependent glucose co-transporter ii being developed for the treatment of type ii diabetes mellitus. this is a singe center, phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of egt0001474 in healthy male and female subjects. in part-1, subjects were randomized to receive single doses of egt0001474 at 2.5-150 mg or placebo in the ratio of 3:1. in part-2, subjects were randomized to receive 14 daily doses of egt0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. when the various doses were analysed, the maximum dose 150 mg was found to be tolerable. although there was no serious adverse events, mild adverse events were observed. this study provided information on human safety, tolerability, pk and pharmacodynamic effects of egt0001474.

Eligibility criteria:
inclusion criteria: * male or female volunteers between the ages of 18 and 55 years inclusive. * in good health. * female subjects must be surgically sterilized or postmenopausal. * body mass index (bmi) between 18 kg/m2 and 30 kg/m2 inclusive. * non-smoker. * negative drug and alcohol screens. exclusion criteria: * abnormal ecg * sitting blood pressure above 140/90 mmhg on 2 evaluations at least 10 minutes apart at screening * treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. * previous treatment with egt0001474. * history of drug abuse. * febrile illness within 5 days prior to the first dose of study medication.

Keywords: diabetes mellitus type 2